NCT00499642

Brief Summary

This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

July 10, 2007

Last Update Submit

December 19, 2007

Conditions

Alzheimer DiseaseHealthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of drug administration on QTc interval.

Interventions

Lecozotan SRDRUG
MoxifloxacinDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women and men aged 18 to 55 years inclusive.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

You may not qualify if:

  • History of any clinically important drug allergy.
  • Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Rennes, 35000, France

Location

Unknown Facility

Rueil-Malmaison, 92502, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecozotanMoxifloxacin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For France: infomedfrance@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

June 1, 2007

Study Completion

August 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

FR(2)